Assessing the efficacy of pelvic floor muscle training and duloxetine on urinary continence recovery following radical prostatectomy: A randomized clinical trial

Rafael Sanchez-Salas; Rafael Tourinho-Barbosa; Arjun Sivaraman; Rafael Castilho Borges; Luigi Candela; Nathalie Cathala; Annick Mombet; Giancarlo Marra; Lara Rodriguez Sanchez; Chahrazad Bey Boumezrag; Camille Lanz; Petr Macek; Fernando Korkes; Xavier Cathelineau

doi:10.1002/pros.24634

Assessing the efficacy of pelvic floor muscle training and duloxetine on urinary continence recovery following radical prostatectomy: A randomized clinical trial

Prostate. 2024 Feb;84(2):158-165. doi: 10.1002/pros.24634. Epub 2023 Oct 30.

Authors

Rafael Sanchez-Salas^{1

2}, Rafael Tourinho-Barbosa^{2

3}, Arjun Sivaraman², Rafael Castilho Borges^{2

3}, Luigi Candela², Nathalie Cathala², Annick Mombet², Giancarlo Marra², Lara Rodriguez Sanchez², Chahrazad Bey Boumezrag⁴, Camille Lanz², Petr Macek², Fernando Korkes³, Xavier Cathelineau²

Affiliations

¹ Department of Surgery, Division of Urology, McGill University, Montreal, Canada.
² Department of Urology, Institut Mutualiste Montsouris, Université Paris-Descartes, Paris, France.
³ Department of Urology, Faculdade de Medicina do ABC (ABC Medical School), São Paulo, Brazil.
⁴ Department of Research, Institut Mutualiste Montsouris, Université Paris-Descartes, Paris, France.

PMID: 37904330
DOI: 10.1002/pros.24634

Abstract

Background: Urinary incontinence (UI) can negatively impact quality of life (QoL) after robot-assisted radical prostatectomy (RARP). Pelvic floor muscle training (PFMT) and duloxetine are used to manage post-RARP UI, but their efficacy remains uncertain. We aimed to investigate the efficacy of PFMT and duloxetine in promoting urinary continence recovery (UCR) after RARP.

Methods: A randomized controlled trial involving patients with urine leakage after RARP from May 2015 to February 2018. Patients were randomized into 1 of 4 arms: (1) PFMT-biofeedback, (2) duloxetine, (3) combined PFMT-biofeedback and duloxetine, (4) control arm. PFMT consisted of pelvic muscle exercises conducted with electromyographic feedback weekly, for 3 months. Oral duloxetine was administered at bedtime for 3 months. The primary outcome was prevalence of continence at 6 months, defined as using ≤1 security pad. Urinary symptoms and QoL were assessed by using a visual analogue scale, and validated questionnaires.

Results: From the 240 patients included in the trial, 89% of patients completed 1 year of follow-up. Treatment compliance was observed in 88% (92/105) of patients receiving duloxetine, and in 97% (104/107) of patients scheduled to PFMT-biofeedback sessions. In the control group 96% of patients had achieved continence at 6 months, compared with 90% (p = 0.3) in the PMFT-biofeedback, 73% (p = 0.008) in the duloxetine, and 69% (p = 0.003) in the combined treatment arm. At 6 months, QoL was classified as uncomfortable or worse in 17% of patients in the control group, compared with 44% (p = 0.01), 45% (p = 0.008), and 34% (p = 0.07), respectively. Complete preservation of neurovascular bundles (NVB) (OR: 2.95; p = 0.048) was the only perioperative intervention found to improve early UCR.

Conclusions: PFMT-biofeedback and duloxetine demonstrated limited impact in improving UCR after RP. Diligent NVB preservation, along with preoperative patient and disease characteristics, are the primary determinants for early UCR.

Keywords: pelvic floor muscle; prostate cancer; quality of life; robot-assisted laparoscopic radical prostatectomy; urinary incontinence.

Publication types

Randomized Controlled Trial

MeSH terms

Duloxetine Hydrochloride / therapeutic use
Humans
Male
Pelvic Floor
Prostatectomy / adverse effects
Quality of Life*
Treatment Outcome
Urinary Incontinence* / etiology
Urinary Incontinence* / therapy

Substances

Duloxetine Hydrochloride